Article Text
Abstract
Introduction Lung cancer (LC) is the leading cause of death from cancer. Early diagnosis of LC is of paramount importance in terms of prognosis. The health authorities of most countries do not accept screening programmes based on low-dose chest CT (LDCT), especially in Europe, because they are flawed by a high rate of false-positive results, leading to a large number of invasive diagnostic procedures. These authorities advocated further research, including companion biological tests that could enhance the effectiveness of LC screening. The present project aims to validate early diagnosis of LC by detection and characterisation of circulating tumour cells (CTCs) in a peripheral blood sample taken from a prospective cohort of persons at high-risk of LC.
Methods and analysis The AIR Project is a prospective, multicentre, double-blinded, cohort study conducted by a consortium of 21 French university centres. The primary objective is to determine the operational values of CTCs for the early detection of LC in a cohort of asymptomatic participants at high risk for LC, that is, smokers and ex-smokers (≥30 pack-years, quitted ≤15 years), aged ≥55 years, with chronic obstructive pulmonary disease (COPD). The study participants will undergo yearly screening rounds for 3 years plus a 1-year follow-up. Each round will include LDCT plus peripheral blood sampling for CTC detection. Assuming 5% prevalence of LC in the studied population and a 10% dropout rate, a total of at least 600 volunteers will be enrolled.
Ethics and dissemination The study sponsor is the University Hospital of Nice. The study was approved for France by the ethical committee CPP Sud-Méditerranée V and the ANSM (Ministry of Health) in July 2015. The findings of the trial will be disseminated through peer-reviewed journals and national and international conference presentations.
Trial registration number NCT02500693.
- screening
- lung cancer
- copd
- cytopathology
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Statistics from Altmetric.com
Footnotes
SL, JB, PH and CHM contributed equally.
Contributors SL, CHM, PH, VH, MI, JB, BP and AM designed the study and protocol submission. SL, CHM and PH wrote the manuscript. DI-B, CP, PC, JC and JM revised the manuscript.
Funding This work is supported by public funding (Conseil Départemental 06, Fondation UNICE, Fondation de France, and Ligue Contre le Cancer -Comité des Alpes-Maritimes).
Competing interests None declared.
Ethics approval National Ethics Committee approval (CPP Sud Méditerranée V on 5 July 2015 (registration no 15.072) and ANSM (Ministry of Health) authorisation were obtained on 8 and 10July 2015.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators The members of the AIR Project Study Group include all authors and François Chabot, MD (HôpitalUniversitaire de Nancy); Gaetan Deslee, MD; Jeanne Marie Perotin, MD (Hôpital Universitaire de Reims); Hervé Mal, MD (Hôpital Bichat); Romain Kessler, MD (Hôpital Universitaire deStrasbourg); Jean-Michel Vergnon, MD; Isabelle Pelissier, MD (HôpitalUniversitaire de St Etienne); Antoine Cuvelier, MD (Hôpital Universitaire de Rouen); Arnaud Bourdin, MD (Hôpital Universitaire de Montpellier); Nicolas Roche, MD (Hôpital Cochin); Stephane Jouneau, MD (Hôpital Universitaire de Rennes); Philippe Bonniaud, MD; Ayoube Zouak, MD (HôpitalUniversitaire de Dijon); Arnaud Scherpereel, MD (Hôpital Universitaire de Lille); Jean Francois Mornex, MD (Hôpital Universitaire de Lyon); Francois Steenhouwer, MD (Hôpital de Roubaix); Johanna Pradelli, MD; Maureen Fontaine; Jennifer Griffonnet; Ariane Guillemart (Hôpital Universitaire deNice); Catherine Butori, MD; Eric Selva(Hôpital Universitaire de Nice); Laurent Plantier, MD; Gaelle Fajolle, MD;Melanie Rayez, MD (Hôpital Universitaire de Tours); Vincent Falle, MD;Nouha Chaabane, MD; Anne Marie Ruppert, MD (Hôpital Tenon); Damien Rouviere, MD; Emilie Bousquet, MD (HôpitalUniversitaire de Toulouse); Faiza Bentayeb, MD; Laurie Pahus, PharmD (Hôpital Universitaire de Marseille); Bernard Aguilaniu, MD; Gilbert Ferretti, MD; and Anne-ClaireToffart, MD (Hôpital Universitaire de Grenoble).